The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver transplant.

Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was <0.5 ug/kg, PEGIFN was permanently discontinued.

Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was <0.5 ug/kg, PEGIFN was permanently discontinued.

Uncontrolled depression or psychiatric disease characterized by current symptoms of major depression or other psychiatric disease or increase in medication for major depression or other psychiatric disease within the past three months.

Uncontrolled autoimmune disease characterized by current symptoms of autoimmune disease or increase in medications within the last three months.

Autoimmune hepatitis

Active substance abuse within 6 months of initiation of treatment

Known intolerance or serious adverse event during prior therapy with interferon or ribavirin

Prior nonresponse after at least 24 weeks of full dose treatment with peginterferon plus ribavirin

Laboratory Model for End-Stage Liver Disease (MELD) score >20. Patients with laboratory MELD score 21-25 may be enrolled if deemed appropriate by the site investigator

Serum creatinine >2.2 mg/dL

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135798

Locations

United States, California

University of California Los Angeles

Los Angeles, California, United States, 90095-7054

University of California San Francisco

San Francisco, California, United States, 94143-0538

United States, Colorado

University of Colorado

Denver, Colorado, United States, 80262

United States, Illinois

Northwestern University Division of Transplantation

Chicago, Illinois, United States, 60611

United States, New York

Columbia University

New York, New York, United States, 10032

United States, Pennsylvania

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19104

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

Virginia Commonwealth University

Richmond, Virginia, United States, 23219

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Schering-Plough

Ortho Biotech Clinical Affairs, L.L.C.

Investigators

Study Chair:

Gregory T. Everson, MD

University of Colorado, Denver

Study Director:

James Everhart, MD

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)